Orange Book product · Brand (NDA)
FLUDEOXYGLUCOSE F18
FLUDEOXYGLUCOSE F-18
At a glance
Nov 21, 2008
Approved
Brand (NDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 21, 2008
17 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
FLUDEOXYGLUCOSE F-18
Strength
20-400mCi/ML
Dosage form
INJECTABLE
Route
INTRAVENOUS
TE code
AP
Application
NDA 021870
Product number
002
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2004FLUDEOXYGLUCOSE F18Brand (NDA)
NDA 021768 · WEILL MEDCL COLL
- 1994FLUDEOXYGLUCOSE F18Brand (NDA)
NDA 020306 · DOWNSTATE CLINCL
- 2025FLUDEOXYGLUCOSE F18Generic (ANDA)
ANDA 216125 · BAMF
- 2020FLUDEOXYGLUCOSE F18Generic (ANDA)
ANDA 209341 · UNIV SOUTHERN CA
- 2020FLUDEOXYGLUCOSE F18Generic (ANDA)
ANDA 210265 · UNIV TX SW MEDCTR
- 2016FLUDEOXYGLUCOSE F18Generic (ANDA)
ANDA 208679 · MEM SLOAN-KETTERING
- 2016FLUDEOXYGLUCOSE F18Generic (ANDA)
ANDA 203942 · KREITCHMAN PET CTR
- 2015FLUDEOXYGLUCOSE F18Generic (ANDA)
ANDA 203736 · MIDWEST MEDCL
- 2015FLUDEOXYGLUCOSE F18Generic (ANDA)
ANDA 203603 · CARDINAL HEALTH 414
- 2015FLUDEOXYGLUCOSE F18Generic (ANDA)
ANDA 203778 · 3D IMAGING DRUG
- 2015FLUDEOXYGLUCOSE F18Generic (ANDA)
ANDA 204759 · KETTERING MEDCTR
- 2015FLUDEOXYGLUCOSE F18Generic (ANDA)
ANDA 204472 · MIPS CRF
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
